Emergent
Status: not approved; being added to U.S. biodefense stockpile
Organizations involved:
Emergent BioSolutions Inc. – Manuf.; R&D; Tech.
Centers for Disease Control & Prevention (CDC) – USA mark.
Bayer HealthCare Pharmaceuticals – Tech.
Bayer Schering Pharma AG – Parent
Cross ref.: See also the Immune Globulin Products entry (#743), the main Anthrax Vaccine entry (#404), and the entries above for other Anthrax Immune Globulin products, particularly the entry for Anthrax Immume Globulin/DVC, the first/current product.
Description: Anthrax immune globulin is an intravenous formulation of immune globulin containing high levels of Bacillus anthracis (anthrax) antibodies derived from pooled plasma of adult volunteers recently immunized with Anthrax Vaccine (BioThrax also from Emergent BioSolutions; see related entry).
Unlike the prior/current anthrax immune globulin product (see entry above), with only small supplies available, this immune globulin has been recently developed, has a higher anthrax-specific immune globulin (antibody) titer, will seek full FDA approval, and, if successful, will likely be manufactured in large quantities for U.S. biodefense stockpiling and/or that of other countries.
Nomenclature: Anthrax immune globulin [BIO]; AIG [SY]
Companies.: Emergent BioSolutions Inc., best known as parent of BioPort Corp., the federal contractor for manufacture of AVA/BioThrax anthrax vaccine (see related entry), with support from the Covalent Group, Inc. is developing this new anthrax human immune globulin containing high titer levels of antibodies from donors who have been vaccinated with BioThrax.
During 2006, the National Institute of Allergy and Infectious Diseases (NIAID) provided funding to the company of up to $3.7 million to support pivotal animal studies and for the development and validation of product assays related to AIG development.
Although, unlike Cangene (see related entry above), Emergent BioSolutions does not currently have a contract for U.S. government purchases of this product, the U.S. and many other governments may be expected to purchase the product, if it receives FDA approval and is priced competitively with that from Cangene,
In Oct. 2008, Anthrax Immune Globulin was designated as covered countermeasures to a public health emergency under the Public Readiness and Emergency Preparedness Act. This act provides liability protection to manufacturers to encourage them to seek defenses for severe health risks like anthrax. The declaration, and by extension the liability protection for Emergent BioSolutions, will remain in effect until Dec. 31, 2015.
Status: This AIG product is being developed as a single-dose intravenous therapeutic for post-exposure treatment of patients with manifest symptoms of anthrax disease resulting from the release of anthrax toxins into the body, i.e., having been infected with Bacillus anthracis.
In Aug. 2006, Emergent BioSolutions reported completing a plasma donor collection program in which plasma was obtained from healthy individuals who had been vaccinated with BioThrax. The amount of plasma obtained was sufficient to produce the first full scale commercial production batch of the AIG, as well as for non-clinical efficacy studies. The company was also designing a healthy donor stimulation program in order to obtain additional quantities of plasma for the production of future commercial production batches.
On March 21, 2007, Emergent BioSolutions filed an IND to begin a pivotal trial to evaluate AIG safety and pharmacokinetics in 105 healthy volunteers. The company anticipates that the trial will be completed within about one year from its commencement, and that no additional clinical trials will be required for FDA approval. The company is relying on the FDA animal rule, which allows use of animal studies, pharmacokinetic trials, etc. to support approvals where testing is infeasible or unethical, e.g.,, challenge studies using live B. anthracis. The company expects to provide pivotal efficacy studies in two animal models, with the timing of those studies dependent upon completion of the development of the models in collaboration with the U.S. government (USAMRIID, Army). The company believes that favorable data from these clinical and non-clinical studies would be sufficient to support FDA for approval.
On March 17, 2009, Emergent BioSolutions began a Phase I/II trial with its Anthrax Immune Globulin (AIG) for the treatment of inhalational anthrax disease. The trial evaluates the safety and pharmacokinetics of AIG in 120 healthy adult volunteers, using three dose levels of a single intravenous infusion of AIG compared to Gamunex. A fourth cohort receives two intravenous infusions of AIG or
Gamunex at equivalent doses administered two days apart will be evaluated.
Tech. transfer: Emergent BioSolutions has reported, "AIG is manufactured using the FDA-approved Gamunex process." Presumably, the company has licensed Gamunex technology from Bayer Corp., Bayer Schering AG. [See the Gamunex entry].
Index Terms:
Companies involvement:
Full monograph
746 Anthrax Immune Globulin/
Nomenclature:
Anthrax immune globulin/Emergent [BIO]
FDA Class: Biologic BLA
antibodies (see also immune globulins; monoclonal antibodies)
biopharmaceutical products
blood products
human materials used<!-- humansource -->
immune globulins, Fab fragments <!-- immunoglobulins -->
anthrax prophylaxis
BHK-21 (C-13)
conjugates
implants
North American coral snake
EU000 Not yet/Never filed with EU
UM100 Controlled/Gov't Distribution in US
US000 never filed/no plans
US666 Biodefense stockpile
EM999 Not Available/Not Marketed in EU
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